Trial document





This trial has been registered retrospectively.
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  DRKS00007708

Trial Description

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Title

Depression and assessement: statistical analysis and examination of credibility
in the context of simulation and aggravation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Aim: investigation of the fakeability respectively simulation (healthy controls) and aggravation (patients) of the most frequently used diagnostic tests in assessments concerning invalidity pension. Construction of a new test by using those items which proved to be most reliable and valid.

We would like to recommend which tests should be used regarding occupational invalidity due to depression as there are no diagnostic-specific guidelines yet.
Validation and standardization of a new test based on our results would be the next step for future research projects. For many years research in the employee selection and forensic domain is concerned with investigating the subjects ability to fake on tests when instructed to do so (Hough et al., 1990; Windle, 1954). There are two distinguishable types of faking: "faking good" means a person´s capability to give more social desirable or more competent answers than they actually are (Viswesyara & Ones, 1999; Birkeland et al., 2006). For faking good subjects are mostly instructed to shift their answers in order to make a good impression or being selected for a job. "Faking bad" means the very reverse: Subjects are guided to present themselves in a more negative manner (e. g. less competent, less social desirable answer and so on). A literature review preceding this study revealed that there are only few studies concerning the credibility in clinical-psychiatric contexts. The rare studies which dealed with affective diseases like depression only focused on tests which include a "lie scale" (e. g. MMPI I & II). However those tests are used once in a blue moon in the psychiatric workaday life as they are very time-consuming (Vossler-Thiess et al., 2013). Most of the more time efficient and commonly used tests (like BDI, HAMD) can be faked (Lees-Hyley & Dunn, 1994; Liske et al., 2008; Merten et al., 2007). However, it must be said that those results only rely on studies with healthy subjects or forensic patients respectively examination subjects. There are no studies examining psychiatric inpatients or outpatients. Additionally there is a lack of studies manipulating systematically the context (for example assessment for invalidity pension) in depressive patients or comparing the intraindividual answer patterns of frequently used diagnostics in order to detect faking.
Impact: The setting of the assessment in the context of occupational invalidity might not be comparable to situations for which the test was orignially constructed. Validation and standardization procedures of such tests normally rely on patients which are not in comparable situations. Concerning the sociomedical question about faking abilities of patients with major depressive disorders is important as the prevalence of depressive disorders and the health care costs increase. Nearly 50% of the invalidity pensions is caused by mental disorders. Mental disorders are - way more than physical diseases - the main reason for early retirements due to illness.
The instruments which are used for diagnostics and determination of severity reagrding depressive smyptoms should be examined with focus on faking sensitivity.
Liske and colleagues (2008) proved that 52% of the subjects in assessments were able to fake bad. To date there is no knowledge about commonly used tests in the context of depression and faking. There is an urgent need for restructing and reforming the actual standard of assessments. This project could be an important milestone. The construction of new and valid tests for assessment situations is very urgent. Central questions: How vulnerable are commonly used depression tests regarding faking bad? Is it possible to detect faking by screening the answer patterns? Which strategies are used by successful fakers? What are the cognitive processes? Can type and extent of faking be forecasted systematically? Are patients with MDD and mild symptoms able to simulate severe symptoms of depression?
Results: n/a as study is still in progress.
The study was carried out according to the Declaration of Helsinki (http://www.wma.net) and had been approved by a local ethics committee (intramural review panel of the Ludwig-Maximilian-University of Munich, Faculty of Medicine).

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Organizational Data

  •   DRKS00007708
  •   2015/02/12
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  •   yes
  •   Approved
  •   172-14, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Clinical sample: Patients with a depressive disorder (F 32, F 33), aged between 18 and 60 years.
    Methods:
    Diagnosis by using the IDCDL (Hiller et al., 1995).
    Afterwards all subjects fill out the NEO-FFI (Borkenau & Ostendorf, 1987), BDI-II (Hautzinger et al., 2005), SCL-90-R (Derogatis, 2002), d2-R (Brickenkamp et al. 1998) and SFSS (Cima et al., 2003). When completing the tests the subjects are instructed to fake good, fake bad or to answer honestly on the tests. The order of these three conditions is randomised as well as the order of the tests to prevent possible sequence effects.
  •   Controls: Healthy adults; same age.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Study aim:
investigation of the fakeability respectively simulation (healthy controls) and aggravation (patients) of the most frequently used diagnostic tests in assessments concerning invalidity pension.

Participants: N = 150 depressive subjects and N = 150 healthy controls.

Method: Personality dimensions (NEO-FFI, Borkenau & Ostendorf, 1987), actual symptoms and mood (BDI-II, Hautzinger et al. 2005; SCL-90-R, Derogatis, 2002)), simulation tendencies (SFSS, Cima et al., 2003), cognitive performance (d-2-R, Brickencamp et al., 1998).

Study duration: 11/01/14-04/30/16

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Secondary Outcome

Construction of a new test by using those items which proved to be reliable and valid.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/14
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Inclusion criteria:
Subjects must be aged between 18 and 60 years. Sufficient spoken and written speech comprehension of the German language must be guaranteed to ensure that the tests are understood by the subjects.
Patients (N = 150): The diagnosis of a depressive disorder must be assured. Subjects can be hospital or ambulant or semiresidential (pschiatric and/or psychotherapeutic) patients.
Controls (N = 150): Physical and mental healthy subjects without mental diseases in their ananmnesis.

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Exclusion Criteria

Exclusion criteria:
Patients: Acute suicidal tendencies, substance addiction, somatic illness including acute/chronic infectious diseases, autoimmune diseases, pregnancy, psychotic disorders, bipolar depression. Patients are additionally excluded if the primary diagnosis is post traumatic stress disorder, general anxiety disorder, social phobia or panic disorder. Other secundary psychiatric diagnosis are tolarated.
Controls: Use of ataractics, somatic illness including acute/chronic infectious diseases, autoimmune diseases, pregnancy as well as mental diseases in their medical history.

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Addresses

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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München
    • Ms.  Dr.  Nina  Sarubin 
    • Nußbaumstraße 7
    • 80336  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München
    • Ms.  Dr.  Nina  Sarubin 
    • Nußbaumstraße 7
    • 80336  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München
    • Ms.  Dr.  Nina  Sarubin 
    • Nußbaumstraße 7
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Dr.-Karl-Wilder-Stiftung (GDV), Abteilung L1
    • Wilhelmstraße 43 / 43 G
    • 10117  Berlin
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München
    • Nussbaumstrasse 7
    • 80336  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/01
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Trial Publications, Results and other Documents

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